Effect of lateral wedge insoles on osteoarthritis knee pain and joint loading: the WEDGE study

niversity of Salford (UK)0 sites42 target enrollmentAugust 8, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 8, 2013

End Date

October 30, 2014

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Salford (UK)

•1\. Aged 40 to 85 years
•2\. Pain with walking (using KOOS question (P5\), they need to have at least mild pain walking on a flat surface)
•3\. On anteroposterior (AP) or Posterior\-Anterior (PA) view x\-ray (weight bearing, if possible) within the last 2 years of screening. They need to have definite medial narrowing and not lateral narrowing and evidence (osteophyte \+ or definite sclerosis) of OA (this would give them Kellgren and Lawrence grade 2 or 3 with medial narrowing). And the absence of patellofemoral osteoarthritis on x\-ray (must be less severe OA that medial disease and cannot be KL3 or higher in patellofemoral joint). Therefore for a patient to be eligible on x\-ray they must fulfil the following criteria:
•3\.1\. KL grade 2 or 3 in the tibiofemoral joint (TFJ)
•3\.2\. The KL grade in the TFJ must be higher than the PFJ and cannot be equal
•3\.3\. The medial joint space narrowing score must be higher that the lateral joint space narrowing score and cannot be equal
•3\.4\. Medial tenderness either by their own indication that this is where they have pain or by examination showing tenderness at the medial TF joint line ? Clinical diagnosis by qualified clinician. Absence of of PF tenderness on examination
•3\.5\. They are able to walk for 100 metres non\-stop
•Target Gender: Male \& Female; Upper Age Limit 85 years ; Lower Age Limit 40 years

•Participants will be excluded if the pain is more localised to the patellofemoral joint on examination than medial joint line, have tricompartmental knee osteoarthritis or have grade 4 medial tibiofemoral osteoarthritis on the Kellgren Lawrence scale.
•Other exclusions include:
•1\. A history of high tibial osteotomy or other realignment surgery or total knee replacement on the affected side
•2\. Knee Arthroscopy with the last 6 months
•3\. Intraarticular injection into the treatment knee in the last 3 months
•4\. Inflammatory arthritis including Rheumatoid Arthritis
•5\. Complex pain conditions such as Diabetic Neuropathic pain, fibromyalgia
•6\. Any foot and ankle problems that will contraindicate the use of the footwear load modifying interventions.
•7\. Severe coexisting medical morbidities
•8\. Use, or have used, orthoses of any description prescribed by a Podiatrist or Orthotist within the last 2 months.